Common Questions
Who is a candidate for osteoporosis drug therapy?
Drug therapy should be considered in the following groups of postmenopausal women:
- Postmenopausal women with T-score < -2.5 in the absence of risk factors
- Postmenopausal women with T-score < -2.0 in the presence of risk factors
The most important risk factors to consider are:
- Personal history of fracture after age 40
- Family history of fracture in a first degree relative (particularly prior to age 80)
- Current cigarette smoking
- Low body weight, < 127 lbs., regardless of height
These guidelines were derived in part for the from the National Osteoporosis Foundation (NOF) cost-effectiveness analysis and several subsequently published RCTs.
Another means of making clinical decisions regarding treatment is through the use of clinical predication rules. FRACTURE is a clinical prediction rule that provides an estimate of the 5-year risk of osteoporotic fracture. This model was developed and validated in populations of women 65 and older and may not accurately predict fractures in younger women (1).
The authors of the original study selected a FRACTURE Index score of 6 or higher as threshold for intervention (1). Users are encouraged to review the original article and those pertaining to the use of clinical decision rules (2).
Drug treatment of osteoporosis should be based on strong evidence that the therapy effectively prevents fractures and that this benefit outweighs economic and health costs for the patient and society. In general, there are several sources of information to help in making treatment decisions:
- Formal cost-effectiveness analysis
- Published consensus guidelines
- Individual randomized controlled trials
Both a formal cost-effectiveness analysis and simple guidelines derived from this process have been published under the sponsorship of the National Osteoporosis Foundation and other groups.
These data can be viewed as general NOF guidelines noted above or by viewing the NOF treatment nomograms. The guide can be viewed in it's entirety via the NOF web site at http://www.nof.org/physguide/entry_form.htm.
- Osteoporosis. Cost-effectiveness analysis and review of the evidence for prevention, diagnosis and treatment. Osteoporos Int 8 1988; 10: S001-S002.
- Cummings SR, Black DM, Thompson DE, et al. Effect of alendronate on risk of fracture in women with low bone density but without vertebral fractures: Results from the Fracture Intervention Trial [see comments].. JAMA 1998; 280: 2077-82.
- Black DM, Cummings SR, Karpf DB, Cauley JA, Thompson DE, Nevitt MC et al. Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Lancet 1996; 348: 1535-41.
- Ensrud KE, Black DM, Palermo L, Bauer C, Barrett-Connor E, Quandt SA et al. Treatment with alendronate prevents fractures in women at highest risk. Arch Intern Med 1997; 157: 2617-2624.
- Liberman UA, Weiss SR, Broll J, Minne HW, Quan H, Bell NH, et al. Effect of oral alendronate on bone mineral density and the incidence of fractures in postmenopausal osteoporosis. N Eng J Med 1995; 333: 1437-43.
- Pols HA, Felsenberg D, Hanley DA, Stepan J, Monoz-Torres M, Wilkins TJ, et al. Multinational, placebo-controlled randomized trial of the effects of alendronate on bone density and fracture risk in postmenopausal women with low bone mass: Results of the FOSIT study. Osteoporos Int 1999; 9: 461-468.
- Harris ST, Watts NB, Genant HK, McKeever CD, Hangartner T et al. Effects of risedronate treatment on vertebral and non-vertebral fractures in women with postmenopausal osteoporosis. JAMA 1999; 282: 1344-1352.
- Reginster JY, Minne HW, Sorensen OH, Hooper M, Roux C, et al. Randomized trial of the effects of risedronate on vertebral fractures in women with established osteoporosis. Osteoporos Int 2000; 11: 83-91.
- McClung MR, Geusen P, Miller PD, Zippel H, Bensen WG, Roux C, et al. Effect of risedronate on the risk of hip fracture in elderly women. N Engl J Med 0000; 344: 333-40.